Surgical face mask
K-Number: K232359 · 2023-10-02
Decision Date2023-10-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Surgical face mask is a medical device manufactured by Kingstar Medical (Xianning) Co., Ltd.. It received FDA 510(k) clearance on 2023-10-02 under approval number K232359. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Surgical face mask?
Surgical face mask is a medical device that received FDA 510(k) clearance on 2023-10-02. It is manufactured by Kingstar Medical (Xianning) Co., Ltd.. The 510(k) number is K232359.
When was Surgical face mask approved by the FDA?
Surgical face mask received FDA 510(k) clearance on 2023-10-02, under approval number K232359.
What company makes Surgical face mask?
Surgical face mask is manufactured by Kingstar Medical (Xianning) Co., Ltd..
What is the FDA product code for Surgical face mask?
The FDA product code for Surgical face mask is FXX.
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K153496Disposable Surgical Face MaskXiantao Rayxin Medical Products Co., Ltd.
K152561Communicator Surgical Facemask with Clear WindowPrestige Ameritech , Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.